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Manufacture of Medicinal Products and the Active
Pharmaceutical Ingredients (APIs) , Bulk Pharmaceutical Ingredients
(BPIs) used as starting materials in the production of these products
is subject to strict good manufacturing practice regulations that are
designed to ensure their quality, safety and efficacy. This ensures
that patients worldwide and at any time can have confidence in the
quality, safety and efficacy of medicines.
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The quality system requirements to identify, select, approve and
qualify vendors of all materials used in the manufacture of BPIs
and medicinal products are clearly defined in the GMP Guidelines.
In addition to GMP regulatory the excipient vendor qualification is
To provide adequate assurance of drug product performance.
to avoid the potential risks mentioned below
• Presence of extraneous matter e.g., metal, paper, particles
• Cross contamination with other chemicals (either
excipients or APIs or breakdown products)
• Contamination with melamine risk materials
which is not permitted by legislation
• Inconsistent manufacture such that the quality of final
products cannot be assured
• mislabeling of containers leading to product mix-up
Concept of Quality by Design (QbD) involves understanding
of product variability in which contribution of excipient also needs
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Registered intermediates usually involve custom synthesis or
process development by the supplier.
The quality system requirements to identify, select, approve and qualify
suppliers of all materials used in the manufacture of APIs and medicinal
products are clearly defined in the GMP Guidelines.
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We are also referring to existing APIC guidance
documents whenever applicable to further clarify
expectations and provide consistency to the processes.
- Quality Agreements
- Auditing Guide,
- APIC Audit Programme
- APIC Quick Guide for BPI Sourcing
- APIC ICH Q7 How to do Document
- APIC Quality Management System Guide for BPI
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Following different dimensions could be assessed:
- Assurance of Supply,
- Quality & Regulatory compliance;
- Cost/Procurement aspects;
- Communication capabilities & responsiveness
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• Perform a packaging component supplier audit.
• Understand which worldwide requirements apply to
packaging component suppliers.
• Use a range of information tools, including the contents of
this module, in support of a packaging component
• Recognize compliance or non-compliance with
regulations pertaining to packaging component supplier’s
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Prior to the audit
• Develop an understanding of the vendor manufacturing process specific to
• Obtain a list of company components that are manufactured at the site.
• Review recent rejections, complaints and issues, of the receiving site(s) and the
• Review any Quality Agreements and relevant registration requirements.
• Review compliance status of the site by checking for service history, recalls
associated with the site, recent regulatory inspections (if applicable) and
• Review previous audit reports and actions During the audit
• Perform a walk through of the manufacturing area. Ensure the production
areas are clean and tidy.
•Ensure the fabric is in good condition and appropriate design for control of the
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Validation and Qualification
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Vallabh Vidhyanagar, Gujarat, India Vendor qualification for
pharmaceutical excipients – GMP requirements and approach K. T. Patel1, N.
Production and Process Controls : Overview of CGMP Regulations and
Guidance for industry: supplier management drug office department of
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
PE00910:Part I and Part II
SUPPLIER QUALIFICATION & MANAGEMENT GUIDELINE
WHO Technical Report Series, No. 902, 2002 :Annex 9 Guidelines on
packaging for pharmaceutical products